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Flow Cytometry and Pharmacokinetic Studies

Article: IPK06 | Received 12 Feb 2020, Accepted 12 Feb 2020, Published online: 21 Apr 2020

References

  • US FDA . Guidance for industry: bioanalytical method validation (2018). http://www.fda.gov/downloads/drugs/guidances/ucm070107.Pdf
  • Piccoli S , Mehta D , Vitaliti A et al. 2019 white paper on recent issues in bioanalysis: FDA immunogenicity guidance, gene therapy, critical reagents, biomarkers and flow cytometry validation (part 3 – recommendations on 2019 fda immunogenicity guidance, gene therapy bioanalytical challenges, strategies for critical reagent management, biomarker assay validation, flow cytometry validation & CLSI H62). Bioanalysis 11(24), 2207–2244 (2019).
  • Bustin SA , Benes V , Garson JA et al. The MIQE guidelines: minimum information for publication of quantitative real-time PCR experiments. Clin. Chem. 55(4), 611–622 (2009).

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